Effects of Bifidobacterium animalis ssp. lactis 420 on gastrointestinal inflammation induced by a nonsteroidal anti-inflammatory drug: A randomized, placebo-controlled, double-blind clinical trial

Abstract

<p>Aims <br></p><p>Use of nonsteroidal anti-inflammatory drugs (NSAIDs) can cause damage to the gastric and duodenal mucosa. Some probiotics have proven useful in ameliorating the harmful side-effects of NSAIDs. Our aim was to evaluate whether oral administration of <em>Bifidobacterium animalis</em> ssp. <em>lactis</em> 420 (B420) can attenuate the increase of calprotectin excretion into faeces induced by intake of diclofenac sustained-release tablets.<br></p><p>Methods <br></p><p>A double-blind, parallel-group, placebo-controlled and randomized clinical study was performed in 50 healthy male and female volunteers aged 20-40 years, in Finland. Study participation consisted of 4 phases: run-in, intervention with B420 or placebo, B420 or placebo + NSAID treatment, and follow-up. The primary outcome was the concentration of calprotectin in faeces. Secondary outcomes were haemoglobin and microbial DNA in faeces and blood haemoglobin levels.<br></p><p>Results <br></p><p>Intake of diclofenac increased the faecal excretion of calprotectin in both groups. The observed increases were 48.19 +/- 61.55 mu g/g faeces (mean +/- standard deviation) in the B420 group and 31.30 +/- 39.56 mu g/g in the placebo group (difference estimate 16.90; 95% confidence interval: -14.00, 47.77; <em>P</em> = .276). There were no significant differences between the treatment groups in changes of faecal or blood haemoglobin. Faecal <em>B. lactis</em> DNA was much more abundant in the B420 group compared to the placebo group (ANOVA estimate for treatment difference 0.85 x 10⁹/g faeces; 95% confidence interval: 0.50 x 10⁹, 1.21 x 10⁹; <em>P</em> < .0001).<br></p><p>Conclusions <br></p><p>Short-term administration of the probiotic B420 did not protect the healthy adult study participants from diclofenac-induced gastrointestinal inflammation as determined by analysis of faecal calprotectin levels.</p>